Long-Term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

This study is ongoing, but not recruiting participants.

First Received: March 27, 2008 Last Updated: February 19, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00650104

Purpose

The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Ropinirole XL (formerly CR)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson''s Disease Who Completed the Previous Ropinirole CR Studies 167 or 164

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety and tolerability are assessed by monitoring AEs, concomitant medications, orthostatic blood pressure/pulse, ECGs, and physical examinations.

Secondary Outcome Measures:

Efficacy is assessed using Clinical Global Impression (Part 1 and 2; for the first year of the study only) and the Unified Parkinson's Disease Rating Scale (UPDRS) (Part II and III).

Estimated Enrollment:	83
Study Start Date:	May 2002
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or non-pregnant/non-breast feeding females
At least 30 years of age
Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)
Completed either Study 167 or Study 164

Exclusion Criteria:

Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
Dizziness or fainting due to orthostatic hypotension on standing
Significant sleep disorder
Drug abuse or alcoholism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650104

Show 25 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101468/196
Study First Received:	March 27, 2008
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00650104 History of Changes
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency

Keywords provided by GlaxoSmithKline:

Parkinson's disease
open-label
long term safety; REQUIP
ropinirole IR

ropinirole CR
ropinirole XL
safety
efficacy

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009